Status:
COMPLETED
Lidocaine Patch for Neck Pain
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Washington D.C. Veterans Affairs Medical Center
Pain Management Institute Bethesda-Washington-Maryland
Conditions:
Neck Pain
Neck Pain, Posterior
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
In this randomized, double-blind, placebo-controlled crossover study, up to 84 patients with non-radicular neck pain will be allocated in a 1:1 ratio to receive up to 3 topical lidocaine or placebo pa...
Detailed Description
84 patients will be allocated to receive lidocaine patch or an identical placebo patch for phase I of this crossover study. Depending on the area of pain, up to 3 patches can be applied. Patches will ...
Eligibility Criteria
Inclusion
- Age 18 to 90 years
- Tenderness to palpation over affected areas (using average 4 kg force for 70 kg person)
- Average pain score \>/= 4 over the week prior to enrollment
- On stable doses of analgesics for 2 weeks prior to enrollment
- Chronic mechanical neck pain \> 3 months in duration
- Boundaries are upper trapezius, mastoid processes, shoulders
Exclusion
- Radicular pain as determined by clinical presentation
- Opioid dose in oral morphine equivalents/day \> 30
- Moderate or severe hepatic disease (will obtain blood work and exclude individuals with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 times the normal range.
- Previous neck surgery
- Known structural defect presumed to be the primary pain generator (e.g. severe degenerative disc or facet joint disease)
- Serious medical (e.g. unstable angina) or psychiatric (e.g. poorly controlled depression, active substance abuse) that could interfere with treatment or pain response
- Secondary gain
- Pregnancy or breastfeeding
- painDETECT score \> 18
- Known allergy to lidocaine
- Diffuse pain phenotype (e.g. fibromyalgia)
- Cervical pain greater in area than 3 patches (10 x 14 cm/patch)
- Skin defects (e.g. burns, active infection) in area(s) of application that could result in significant systemic absorption
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 2 2023
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT04378959
Start Date
February 1 2021
End Date
June 2 2023
Last Update
August 8 2023
Active Locations (2)
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1
DC VA Medical Center
Washington D.C., District of Columbia, United States, 20422
2
Johns Hopkins Blaustein Pain Treatment Center
Baltimore, Maryland, United States, 21205